Toric Intraocular Lens (IOL) Implantation for Management of Cataracts

Sponsor
Eye & ENT Hospital of Fudan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05797298
Collaborator
(none)
3,000
2
60
1500
25

Study Details

Study Description

Brief Summary

This study included cataract patients who underwent toric intraocular lens (IOL) implantation, which aimed to evaluate the stability and clinical visual quality of toric IOLs.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study included cataract patients who underwent the implantation of toric intraocular lens (IOL) with haptic design, which aimed to evaluate the stability and clinical visual quality of toric IOLs.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Plate-haptic Toric Intraocular Lens (IOL) Implantation for Management of Cataracts
    Actual Study Start Date :
    Jun 1, 2019
    Anticipated Primary Completion Date :
    Mar 31, 2024
    Anticipated Study Completion Date :
    May 31, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    cataract patients implanted with toric IOLs

    Cataract patients who received the implantation of different toric IOLs with different haptic designs

    Outcome Measures

    Primary Outcome Measures

    1. IOL rotation degree at one hour [one hour]

      After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

    2. IOL rotation degree at one day [one day]

      After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

    3. IOL rotation degree at three days [three days]

      After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

    4. IOL rotation degree at one week [one week]

      After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

    5. IOL rotation degree at two weeks [two weeks]

      After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

    6. IOL rotation degree at one month [one month]

      After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

    7. IOL rotation degree at three months [three months]

      After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

    8. IOL rotation degree at six months [six months]

      After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

    9. IOL rotation degree at one year [one year]

      After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

    10. IOL rotation degree at three years [three years]

      After the pupil was dilated, the IOL axis was recorded using the same slit-lamp microscope. IOL rotation was defined as the difference between the target and final axis.

    11. IOL tilt at one week [one week]

      The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.

    12. IOL tilt at two weeks [two weeks]

      The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.

    13. IOL tilt at one month [one month]

      The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.

    14. IOL tilt at three months [three months]

      The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.

    15. IOL tilt at six months [six months]

      The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.

    16. IOL tilt at one year [one year]

      The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.

    17. IOL tilt at three years [three years]

      The tilt data were obtained from the wavefront mode of the OPD-Scan III aberrometer.

    18. IOL decentration at one week [one week]

      Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.

    19. IOL decentration at two weeks [two weeks]

      Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.

    20. IOL decentration at one month [one month]

      Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.

    21. IOL decentration at three months [three months]

      Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.

    22. IOL decentration at six months [six months]

      Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.

    23. IOL decentration at one year [one year]

      Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.

    24. IOL decentration at three years [three years]

      Decentration was defned as the distance between the center of the toric IOL and the visual axis and was calculated using Adobe Photoshop software on the retro image exported from the OPD-scan aberrometer.

    Secondary Outcome Measures

    1. visual quality at one week [one week]

      visual acuity was evaluated by OPD-Scan III aberrometer.

    2. visual quality at two weeks [two weeks]

      visual acuity was evaluated by OPD-Scan III aberrometer.

    3. visual quality at one month [one month]

      visual acuity was evaluated by OPD-Scan III aberrometer.

    4. visual quality at three months [three months]

      visual acuity was evaluated by OPD-Scan III aberrometer.

    5. visual quality at six months [six months]

      visual acuity was evaluated by OPD-Scan III aberrometer.

    6. visual quality at one year [one year]

      visual acuity was evaluated by OPD-Scan III aberrometer.

    7. visual quality at three years [three years]

      visual acuity was evaluated by OPD-Scan III aberrometer.

    Other Outcome Measures

    1. visual acuity at one day [one day]

      uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one day

    2. visual acuity at three days [three days]

      uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at three days

    3. visual acuity at one week [one week]

      uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one week

    4. visual acuity at two weeks [two weeks]

      uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at two weeks

    5. visual acuity at one month [one month]

      uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one month

    6. visual acuity at three months [three months]

      uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at three months

    7. visual acuity at six months [six months]

      uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at six months

    8. visual acuity at one year [one year]

      uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at one year

    9. visual acuity at three years [three years]

      uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) were recorded after surgery at three years

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Cataract
    Exclusion Criteria:
    • • small pupil

    • zonular dehiscence

    • preexisting corneal pathology

    • glaucoma

    • uveitis

    • a history of ocular trauma or surgery

    • severe intraoperative and postoperative complications

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eye & ENT Hospital of Fudan University Shanghai Shanghai China 200031
    2 Eye & ENT Hospital of Fudan University Shanghai China 200031

    Sponsors and Collaborators

    • Eye & ENT Hospital of Fudan University

    Investigators

    • Principal Investigator: Jin Yang, PhD, Eye & ENT Hospital of Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jin Yang, Professor, Eye & ENT Hospital of Fudan University
    ClinicalTrials.gov Identifier:
    NCT05797298
    Other Study ID Numbers:
    • Toric IOL
    First Posted:
    Apr 4, 2023
    Last Update Posted:
    Apr 4, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 4, 2023